Alectinib Hydrochloride

Phase III (Krascendo 1) demonstrates best-in-class potential for patients with previously treated advanced KRAS G12C non-small cell lung cancer Divarasib showed clinically meaningful improvements in progression-free survival compared to approved KRAS G12C inhibitors; no new safety signals were observed Statistical significance for overall survival was achieved at the interim analysis in this poor-prognosis patient population Data will be submitted to health authorities and presented at an upcoming medical meeting 02 July 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today positive results from the phase III Krascendo 1 study evaluating divarasib, an investigational next-generation KRAS G12C inhibitor, against the approved, first generation KRAS G12C inhibitors sotorasib or adagrasib in patients with previously treated KRAS G12C non-small cell lung cancer (NSCLC). The study met its primary and key secondary endpoint, with divarasib achieving clinically meaningful and statistically significant improvements in both progression-free survival (PFS) and overall survival (OS). The safety pro divarasib remained consistent with previous data, with no new findings detected and the most common treatment-related events being manageable and reversible. “The superior survival demonstrated in this global head-to-head comparison of KRAS G12C inhibitors confirms the potential of divarasib to improve clinical outcomes for people with KRAS G12C non-small cell lung cancer,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “These results should establish divarasib as a new standard of care for previously-treated lung cancer patients with this genetically defined tumor subtype.” Efficacious treatments for KRAS G12C NSCLC represent a significant unmet need in lung cancer care. The G12C mutation is one of the most common KRAS oncogene mutations, found in approximately 14% of NSCLC cases and associated with poor prognosis for patients.1,2 Roche is advancing a comprehensive phase III clinical development programme in NSCLC, investigating divarasib as both a monotherapy and as a chemotherapy-free combination, across different disease settings and lines of therapy. The US Food and Drug Administration granted Breakthrough Therapy Designation to divarasib in 2022, and in 2026, Orphan Drug Designation for KRAS G12C non-small cell lung cancer (NSCLC). Data from the Krascendo 1 study will be presented at an upcoming medical meeting and submitted to health authorities with the aim of bringing this potential treatment option to people with KRAS G12C NSCLC as soon as possible. The Krascendo 1 study [NCT06497556] is the only global head-to-head study evaluating a Kirsten rat sarcoma virus (KRAS) G12C inhibitor in direct comparison with first generation KRAS G12C inhibitors.3 This phase III, randomised, open-label, multicentre study evaluates the efficacy and safety of divarasib monotherapy versus sotorasib or adagrasib in people with previously treated KRAS G12C-mutant advanced or metastatic non-small cell lung cancer.3 The study includes 338 adults, randomised to receive either divarasib (once daily) or, either sotorasib (once daily) or adagrasib (twice daily).3 The primary endpoint is blinded independent central review (BICR)-assessed progression-free survival.3 Secondary endpoint measures include overall survival, confirmed objective response, duration of response, as well as other efficacy and safety measures.3 Divarasib is an investigational, next-generation, oral, KRAS G12C inhibitor. It has shown greater potency and selectivity in preclinical studies compared with first generation KRAS G12C-targeting treatments, sotorasib and adagrasib.4,5 Divarasib is designed to selectively bind to the KRAS G12C protein, locking the protein in an inactive (‘off’) state, thereby turning off its tumour-driving signalling.6 Divarasib’s comprehensive clinical development programme is anchored by three phase III studies: Despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths worldwide, surpassing the combined mortality rates of breast, prostate, and stomach cancers.7,8 Each year, it claims the lives of 1.8 million people, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of cases.7,9 KRAS is one of the most frequently mutated genes in lung cancer, occurring in approximately 25% of newly diagnosed lung cancers.10 The G12C mutation is one of the most common KRAS mutations, found in approximately 14% of NSCLC cases.1 The KRAS gene produces the KRAS protein, which acts as a cellular control switch, cycling between an active ('on') and inactive ('off') state to regulate cell growth and proliferation, making it a critical target for new therapeutic strategies.10 The G12C mutation locks the KRAS protein in its active ('on') state, leading to continuous, unregulated signalling for cell growth, driving tumour proliferation.6,10 Roche is committed to advancing the field of lung cancer treatments, leveraging more than 20 years of deep scientific expertise to improve patient outcomes and their overall experience. Roche’s strong commitment to investment in research and development has built a robust portfolio of approved medicines and companion diagnostics, which empowers physicians to better understand a patient's disease and optimise care. Roche’s broad portfolio includes approved medicines such as Alecensa® (alectinib), Tecentriq® (atezolizumab), and Rozlytrek® (entrectinib). Its extensive pipeline includes investigational treatments across three key focus areas: small cell lung cancer, non-small cell lung cancer (NSCLC) with actionable genomic alterations (AGA), and NSCLC without AGA. Utilising diverse approaches, ranging from cancer-cell-killing ‘cytotoxics’ and immunotherapies to treatments targeting specific characteristics of cancer cells, we aim to translate scientific discoveries into meaningful progress in patient care. Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. References [1] Nassar AH, et al. Distribution of KRAS (G12C) Somatic Mutations across Race, Sex, and Cancer Type. N Engl J Med 2021; 384 (2): 185-187. [2] Wankhede, Durgesh, et al. Prognostic role of KRAS G12C mutation in non-small cell lung cancer: a systematic review and meta-analysis. Diagnostics 13.19 (2023): 3043. [3] Gadgeel S, et al. P3.12D.07 Divarasib Versus Adagrasib or Sotorasib in Pretreated KRAS G12C+ Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC). J of Thorac Oncol. 2024; 19 (10, Supplement): S349. [4] Endres NF, et al. Discovery and Characterization of Divarasib (GDC-6036), a Potent Covalent Inhibitor of KRAS G12C. J Med Chem 2026; 69 (5): 5147-5165. [5] Landry ML, et al. Discovery and Optimization of a Potent, Efficacious, and Brain-Penetrant Inhibitor of KRAS G12C. J Med Chem 2026; 69 (5): 5241-5258. [6] Friedlaender A, et al. KRAS as a druggable target in NSCLC: rising like a phoenix after decades of development failures. Cancer Treat Rev. 2020;85:101978. [7] World Health Organization. Global cancer burden growing, amidst mounting need for services [Internet; cited 2026 June]. [8] American Lung Association. Lung Cancer Statistics [Internet; cited 2026 June]. [9] World Health Organization. Lung cancer [Internet; cited 2026 June]. [10] Pakkala S, et al. Personalized therapy for lung cancer: striking a moving target. JCI Insight 2018; 3 (15). The content above comes from the network. if any infringement, please contact us to modify.

Highlighting advanced manufacturing capabilities, stringent quality standards, and reliable supply for pharmaceutical innovation worldwide. CALIFORNIA, CA, UNITED STATES, June 10, 2026 / EINPresswire.com / -- SHANDONG, China — As global demand for cost-effective and high-quality pharmaceutical intermediates intensifies, three Chinese manufacturers have emerged as key players in supplying the building blocks for active pharmaceutical ingredients (APIs) used in anti-cancer, antiviral, and chronic disease therapies. Haohong (Qihe) Pharmaceutical Technology Co., Ltd., Zhejiang Huahai Pharmaceutical Co., Ltd., and CSPC Pharmaceutical Group Limited represent distinct segments of the market, each offering specialized capabilities that power drug development pipelines worldwide. Industry Context The pharmaceutical intermediate market, estimated at over $40 billion globally in 2025, is projected to grow at a compound annual growth rate of 6-7% through 2030, driven by increasing R&D investments in targeted therapies and generic drug manufacturing. Chinese manufacturers collectively account for more than 30% of global intermediate supply, leveraging integrated chemical synthesis capabilities and cost advantages. Within this landscape, companies differentiate themselves through purity standards, batch consistency, regulatory compliance, and customized synthesis services. Company Profiles and Competitive Strengths Haohong (Qihe) Pharmaceutical Technology Co., Ltd., established in 2021 and based in Shandong Province, specializes in high-grade active pharmaceutical intermediates and custom synthesis. The company employs approximately 75 staff and operates a 3,000-square-meter manufacturing facility with an annual production capacity of 1,000 tons. Export business accounts for 40% of total sales, with products reaching the United States, Europe, Japan, India, and Bangladesh. Haohong holds ISO 9001:2015 certification and was recognized as a Technology-based Small and Medium-sized Enterprise in 2024 and awarded Innovative Small and Medium-sized Enterprise of Shandong Province in 2025. Its research and development team comprises 30 engineers, supporting custom synthesis from gram scale to hundreds of kilograms. The production base in Liaocheng is equipped with 30 sets of 3,000–5,000L reactors. The company focuses on anti-cancer, anti-hepatitis C, and anti-diabetic intermediates, including key products for Apalutamide, Abemaciclib, and Alectinib. Haohong’s competitive edge lies in its ability to deliver ultra-high purity (≥98%) with strict impurity control and batch-to-batch consistency, supported by complete technical documentation compliant with ICH and GMP standards. The company also holds multiple utility model patents for production equipment, including a waste gas absorption device and a gas chromatography detection system. Zhejiang Huahai Pharmaceutical Co., Ltd. (SZSE: 600521), founded in 1998 and headquartered in Linhai, Zhejiang, is one of China’s largest API and intermediate manufacturers. Huahai specializes in cardiovascular, central nervous system, and anti-cancer drugs. It operates multiple FDA- and EMA-approved facilities and exports to over 50 countries. Huahai’s strength lies in its vertically integrated supply chain, extensive regulatory dossier library (more than 100 ANDAs), and large-scale production capacity exceeding 5,000 tons per year for certain intermediates. The company has a robust R&D pipeline and is a preferred partner for branded generic drug manufacturers in the United States and Europe. Huahai’s market capitalization exceeds $3 billion, reflecting its established position. CSPC Pharmaceutical Group Limited (HKEx: 1093), founded in 1938 and headquartered in Shijiazhuang, Hebei, is a leading Chinese pharmaceutical conglomerate with a strong presence in innovative drug development and bulk intermediates. With over 20,000 employees and annual revenue exceeding $4 billion, CSPC manufactures a wide range of chemical intermediates, APIs, and finished formulations. The company has a dedicated oncology intermediate division, producing key precursors for drugs like lenvatinib and olaparib. CSPC differentiates itself through its proprietary continuous flow chemistry technology and its ability to scale from laboratory to commercial production rapidly. The group holds multiple patents on synthesis routes and is a major supplier to multinational pharmaceutical companies for clinical trial materials. Comparative Advantages While Huahai and CSPC dominate in scale, regulatory approvals, and global brand recognition, Haohong positions itself as a specialized, high-agility partner for customers requiring high-purity custom intermediates, particularly in the oncology and targeted therapy space. Haohong’s strengths include timely delivery, stable batch quality, comprehensive technical documentation, and a flexible approach to custom synthesis—from gram-scale R&D batches to metric ton-level commercial supply. According to internal comparison data, Haohong’s product purity is on average 0.02% higher than industry peers, and batch quality stability is 10% above the industry average. The company’s self-owned factory and deep R&D capabilities allow it to offer competitive pricing without compromising quality. Market Impact and Analyst Perspective The diversification of intermediate suppliers is critical for global drug developers seeking supply chain resilience. “Companies like Haohong fill a niche for project-specific, high-purity intermediates that require close collaboration and rapid turnaround,” said a pharmaceutical supply chain analyst based in Shanghai. “While large players offer volume, smaller specialized manufacturers often provide better customization and faster response times.” The trend toward more complex targeted therapies, such as antibody-drug conjugates and protein degraders, demands higher purity intermediates with controlled chiral and steric properties—areas where dedicated Chinese manufacturers are investing heavily. Outlook As the global pharmaceutical industry continues to outsource intermediate production, the three companies highlighted are expected to capture growing demand. Haohong plans to expand its reactor capacity and pursue additional industry certifications. Huahai is investing in continuous manufacturing platforms. CSPC is accelerating its innovative drug pipeline, which in turn drives demand for proprietary intermediates. The competitive landscape in China remains fragmented, but specialized players with strong technical foundations and international traceability are well-positioned for growth. For more information about Haohong Pharmaceutical ’s product range and capabilities, download the company brochure: Haohong Corporate Brochure Contact: Xu Tianxia | Email: Xutx@haohong-pharma.com | Tel: +86 180-6854-1569 Address: Block B, building 3, accelerator, high tech Zone, Qihe County, De Zhou City, Shandong Province, China Website: www.haohong-pharma.com Xu Tianxia Haohong (Qihe) Pharmaceutical Technology Co., Ltd + +86 180-6854-1569 Xutx@haohong-pharma.com Visit us on social media: Other Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.